Clinical trial · Interventional
Study on the Effectiveness and Safety of CLE Combined With Cryobiopsy for Diagnosis of Pulmonary Lesions
Study on the Effectiveness and Safety of Confocal Laser Endomicroscopy Combined With Ultrafine Cryoprobe for Biopsy Diagnosis of Pulmonary Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Forty subjects meeting the inclusion and exclusion criteria were recruited at a single center and signed informed consent forms. Among them, 20 patients in the diffuse group and 20 patients in the localized group were randomly assigned to the conventional radial endobronchial ultrasound combined with cryobiopsy group (conventional group) and the confocal laser endomicroscopy combined with cryobiopsy group (combined group). During the operation, the operator manipulated the bronchoscope to reach the lesion. After confirming the arrival at the lesion using radial endobronchial ultrasound/confocal laser endomicroscopy, cryobiopsy was performed, and the size of the sample was recorded. CBCT scanning was conducted after cryobiopsy. If there was no hole-in-lesion image, cryobiopsy was performed again under CBCT guidance. CBCT scanning was performed after biopsy to determine whether there were any adverse events.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Pulmonary Lesion | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Confocal laser endomicroscopy combined cryobiopsy | Other | — | UNRESOLVED |
| Conventional cryobiopsy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- ACTIVE_COMPARATOR
- label
- Diffuse- Conventional Group
- description
- The Diffuse-Conventional Group used conventional cryobiopsy for lung lesions.
- interventionNames
- Other: Conventional cryobiopsy
- type
- EXPERIMENTAL
- label
- Diffuse- Combined Group
- description
- The Diffuse-Combined Group used CLE combined with cryobiopsy for lung lesions
- interventionNames
- Other: Confocal laser endomicroscopy combined cryobiopsy
- type
- ACTIVE_COMPARATOR
- label
- Localized - Convention Group
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients over 18 years old with lung lesions indicated by chest CT; 2. Preoperative CT indicates that the lung lesion to be biopsied has a bronchus leading to it; 3. Able to understand and voluntarily sign the written informed consent form. - Exclusion Criteria: 1. Patients with contraindications to anesthesia or bronchoscopy; 2. Patients with uncorrectable coagulation disorders; 3. Patients who cannot discontinue therapeutic anticoagulants within an appropriate time interval before surgery; 4. Patients with severe liver or kidney dysfunction, mental illness, etc.; 5. Pregnant or lactating patients; 6. Patients without a clear histological or clinical diagnosis; 7. Subjects deemed unsuitable for participation in this study by the investigator.
References
Publications (3)
- BACKGROUNDKramer T, Wijmans L, de Bruin M, van Leeuwen T, Radonic T, Bonta P, Annema JT. Bronchoscopic needle-based confocal laser endomicroscopy (nCLE) as a real-time detection tool for peripheral lung cancer. Thorax. 2022 Apr;77(4):370-377. doi: 10.1136/thoraxjnl-2021-216885. Epub 2021 Jun 25. PMID 34172559
- BACKGROUNDWellikoff AS, Holladay RC, Downie GH, Chaudoir CS, Brandi L, Turbat-Herrera EA. Comparison of in vivo probe-based confocal laser endomicroscopy with histopathology in lung cancer: A move toward optical biopsy. Respirology. 2015 Aug;20(6):967-74. doi: 10.1111/resp.12578. Epub 2015 Jun 19. PMID 26094505
- BACKGROUNDSorokina A, Danilevskaya O, Averyanov A, Zabozlaev F, Sazonov D, Yarmus L, Lee HJ. Comparative study of ex vivo probe-based confocal laser endomicroscopy and light microscopy in lung cancer diagnostics. Respirology. 2014 Aug;19(6):907-13. doi: 10.1111/resp.12326. Epub 2014 Jun 9. PMID 24909555